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FDA 510(k)

HILINE™ Fixation System

K-Number: K230565 · 2023-04-20

ApplicantGlobus Medical, Inc.
Decision Date2023-04-20
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HILINE™ Fixation System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2023-04-20 under approval number K230565. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HILINE™ Fixation System?

HILINE™ Fixation System is a medical device that received FDA 510(k) clearance on 2023-04-20. It is manufactured by Globus Medical, Inc.. The 510(k) number is K230565.

When was HILINE™ Fixation System approved by the FDA?

HILINE™ Fixation System received FDA 510(k) clearance on 2023-04-20, under approval number K230565.

What company makes HILINE™ Fixation System?

HILINE™ Fixation System is manufactured by Globus Medical, Inc..

What is the FDA product code for HILINE™ Fixation System?

The FDA product code for HILINE™ Fixation System is OWI.

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Other Devices by Globus Medical, Inc.

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Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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